Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
756
Countries
11
Sites
49
Obesity
This trial aims to investigate the efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in participants with a BMI ≥27 kg/m^2 and T2DM. Primary objective is to demonstrate superiority of survodutide low and high dose against p…
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 18 Jan 2024 → 27 Mar 2026
- Decision date (initial)
- 2024-01-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502531-18-00
- WHO UTN
- U1111-1289-0247
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Others
This trial aims to investigate the efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in participants with a BMI ≥27 kg/m^2 and T2DM.
Primary objective is to demonstrate superiority of survodutide low and high dose against placebo.
Secondary objectives 1
- Demonstrate superiority of survodutide low dose and high dose against placebo in regards to the secondary endpoints listed in section 2.1.3 of the CTP.
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 21.1 | LLT | 10045242 | Type II diabetes mellitus | 10027433 |
Study design 5 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Screening
|
Not Applicable | None | all participants: all participants | |
| 2 | Dose escalation part Dose escalation part
|
Randomised Controlled | Double | [{"id":162408,"code":3,"name":"Monitor"},{"id":162406,"code":2,"name":"Investigator"},{"id":162407,"code":5,"name":"Carer"},{"id":162409,"code":4,"name":"Analyst"},{"id":162405,"code":1,"name":"Subject"}] | BI 456906 low dose: BI 456906 low dose BI 456906 high dose: BI 456906 high dose Placebo: Placebo |
| 3 | Dose maintenance part Dose maintenance part
|
Randomised Controlled | Double | [{"id":162411,"code":1,"name":"Subject"},{"id":162415,"code":5,"name":"Carer"},{"id":162413,"code":4,"name":"Analyst"},{"id":162414,"code":2,"name":"Investigator"},{"id":162412,"code":3,"name":"Monitor"}] | BI 456906 low dose: BI 456906 low dose BI 456906 high dose: BI 456906 high dose Placebo: Placebo |
| 4 | Follow-up period Follow-up period
|
Not Applicable | None | all participants: all participants | |
| 5 | Follow-up 2 period Follow-up 2 period
|
Not Applicable | None | additional follow-up for selected group of participants: "- trial participants who have cross-reactive antibodies against endogenous GLP-1 and/or glucagon at Week 60, - or who have unresolved serious, immune-related AEs at the FU Visit, - or trial participants who prematurely discontinue the IMP" |
Regulatory references
- Scientific advice from competent authorities
- Center For Drug Evaluation, European Medicines Agency, Food And Drug Administration, Pharmaceuticals And Medical Devices Agency
- Plan to share IPD
- Yes
- IPD plan description
- Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- BMI ≥27 kg/m^2 at screening
- Diagnosed with T2DM (defined as glycosylated haemoglobin A1c [HbA1c] ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
- HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening
- Currently treated for T2DM with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Further inclusion criteria apply.
Exclusion criteria 9
- Body weight change (self-reported) of >5% within 3 months before screening
- Treatment with any medication for the indication obesity within 3 months before screening
- Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before the screening visit up to and including the randomisation visit (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and dipeptidyl peptidase 4 inhibitor [DPP-4i])
- QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- Heart failure (HF) with NYHA class IV
- Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
- History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x ULN as measured by the central laboratory at screening
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage change in body weight from baseline to Week 76
- Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Secondary endpoints 4
- Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
- Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
- Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
- Absolute change from baseline to Week 76 in: o Body weight (kg) o HbA1c (%) o Waist circumference (cm) o SBP (mmHg) o “Capacity to Resist” domain score of Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scael)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
PRD10189602 · Product
- Active substance
- Survodutide
- Substance synonyms
- BI 456906, H-His-Ac4c-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Tyr-Ser-Lys-Tyr-Leu-Asp-Glu-Arg-Ala-Ala-Lys-Asp-Phe-Ile-Lys(HOOC-(CH2)16-CO-γGlu-Gly-Ser-Gly-Ser-Gly-Gly-)-Trp-Leu-Glu-Ser-Ala-NH2
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189603 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189601 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189622 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189621 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189613 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
PRD10189614 · Product
- Active substance
- BI 456906
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring, Code 12 |
Boehringer Ingelheim RCV GmbH & Co. KG
- Sponsor organisation
- Boehringer Ingelheim RCV GmbH & Co. KG
- Address
- Dr.-Boehringer-Gasse 5-11, Meidling Meidling
- City
- Vienna
- Postcode
- 1121
- Country
- Austria
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
11 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 7 | 4 |
| Czechia | Ended | 33 | 5 |
| Denmark | Ended | 13 | 3 |
| Finland | Ended | 21 | 3 |
| Germany | Ended | 45 | 6 |
| Greece | Ended | 18 | 3 |
| Hungary | Ended | 16 | 5 |
| Netherlands | Ended | 2 | 4 |
| Poland | Ended | 51 | 5 |
| Spain | Ended | 30 | 6 |
| Sweden | Ended | 12 | 5 |
| Rest of world
Australia, New Zealand, Japan, United Kingdom, China, Korea, Republic of, United States, Canada
|
— | 508 | — |
Investigational sites
Algemeen Stedelijk Ziekenhuis Campus Aalst
Department of Cardiology, Merestraat 80, 9300, Aalst
UZ Brussel
UZ Brussel, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Delta
AZ Delta - Campus Rumbeke, Deltalaan 1, 8800, Roeselare
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Edumed s.r.o.
Private Practice, Mlynska 189, 547 01, Nachod
DIEKO s.r.o.
Private Practice, Karlovarska 1632/30, Severni Predmesti, Plzen 1
Private Practice - Dr. Barbora Diepoltova
Private Practice, Axmanova 131, 19014, Prague
Milan Kvapil s.r.o.
Private Practice, Michnova 1622/4, Chodov, Prague
NZZ Agentura Science Pro, s.r.o.
Diabetologic Ambulatory, Dlouha 521/34, 77900, Olomouc
Nordsjaellands Hospital
Nordsjællands Hospital Hillerød, Dyrehavevej 29, 3400, Hilleroed
Sanos A/S
Sanos Clinic Gandrup (SMO), Borgergade 39, 9362, Gandrup
Hvidovre Hospital
Copenhagen University Hospital - Hvidovre, Kettegaard Alle 30, 2650, Hvidovre
Health Step Finland Oy
Kuopion kampus, Medistudia 5krs H5247, Medistudia 5th Floor, Yliopistonranta 1 A, Kuopio
HUS Helsinki University Hospital
Lihavuustutkimusyksikkö Biomedicum Helsinki 1, Haartmaninkatu 4, 00290, Helsinki
Clinical Research Services Turku Oy
CRST Oy - Clinical Research Services Turku Oy, Itainen Pitkakatu 4b, 20520, Turku
Institut fuer Diabetesforschung Muenster GmbH
Innere Medizin, Angiologie & Diabetologie, Ernährungsmedizin, Hohenzollernring 70, Herz-Jesu, Muenster
MVZ im Altstadt-Carree Fulda GmbH
Medizinisches Versorgungszentrum, Dalbergstrasse 22, Innenstadt, Fulda
KliFoCenter GmbH
KliFo Center GmbH, Diakonissenstrasse 8, Mitte, Witten
Diabetologische Schwerpunktpraxis
Private Practice, Beselerstraße 2a, 21073, Hamburg
Red Institut Fur Medizinische Forschung Und Weiterbildung
Institut für Med. Forschung und Fortbildung Innere Medizin/Diabetologie, Markt 15, 23758, Oldenburg In Holstein
InnoDiab Forschung GmbH
InnoDiab Forschung GmbH, Eleonorastrasse 42, Ruettenscheid, Essen
Thermi Clinic S.A.
Thermi Clinic - Internal Medicine Clinic, 14th Kms N Moudanion, 570 01, Thessaloniki
Euromedica General Clinic Of Thessaloniki
Department of Endocrinology Diabetes and Metabolism, Kallas Marias 11, Gravias 2, Thessaloniki
Athens Medical Center S.A.
Diabetes & Obesity Unit, Distomou 5-7, 151 25, Maroussi
Pest Megyei Flor Ferenc Korhaz
5th Department of Internal Medicine, Semmelweis Ter 1, 2143, Kistarcsa
Belinus Bt.
Private Practice, Erzsebet Utca 11-13, 4025, Debrecen
DRC Kft.
Private Practice, Ady Endre Utca 12/b, 8230, Balatonfured
University Of Szeged
I. Intern Clinic, Kalvaria Sugarut 57, 6725, Szeged
Arina Trial Research Kft.
Private Practice, Kigyo Utca 24, 5900, Oroshaza
Sint Franciscus Vlietland Groep Stichting
Franciscus Gasthuis, Kleiweg 500, 3045 PM, Rotterdam
Universitair Medisch Centrum Groningen
Dept. of Internal Medicine, Hanzeplein 1, 9713 GZ, Groningen
Stichting Treant Ziekenhuiszorg
Bethesda Diabetes Research Center, Hoogeveen, Dr. G.h. Amshoffweg 1, 7909 AA, Hoogeveen
PreCare Trial & Recruitment B.V.
Dr. V.E.K.M. van de Walle, Kasteelhof 5, 6121 XK, Born
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
Private Practice, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Velocity Nova Sp. z o.o.
Specialized Physician's Office KO-MED, Ul. Waclawa Sieroszewskiego 34, 24-100, Pulawy
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Private Practice, Ul. Na Zaspe 3, 80-546, Gdansk
Lukmed 2 Sp. z o.o.
Private Practice, Ul. Mlynarska 16 B, 08-110, Siedlce
Metabolica Sp. z o.o.
Private Practice, Ul. Najswietszej Marii Panny 9b, 33-100, Tarnow
Hospital General Universitario Gregorio Maranon
Servicio de Endocrinología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Servicio de Endocrinología, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Nisa Sevilla Aljarafe
Servicio de Endocrinología, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Clinica Universidad De Navarra
Servicio de Endocrinología, Avenue Pio XII 36, 31008, Pamplona
University Hospital Of Canary Islands
Servicio de Endocrinología, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Complexo Hospitalario Universitario A Coruna
Servicio de Endocrinología, Lugar Jubias De Arriba 84, 15006, A Coruna
Ladulaas AB
Ladulaas Kliniska Studier, Skaraborgsvagen 35e, Boras Caroli, Boras
Stift Carlanderska Sjukhuset
Forskningsenheten Carlanderska, Carlandersparken 1, 412 55, Goteborg
PharmaSite AB
Pharmasite Malmö, Foreningsgatan 26, Malmo S:t Johannes, Malmo
Region Oerebro Laen
Akademiskt specialistcentrum, Sodra Grev Rosengatan, 701 85, Orebro
Region Stockholm – SLSO
Medicinmottagning 5/Överviktsenheten, Solnavagen 1 E, S:t Matteus, Stockholm
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-01-18 | 2026-02-05 | 2024-02-06 | 2024-05-28 | |
| Czechia | 2024-01-24 | 2026-03-11 | 2024-02-26 | 2024-05-28 | |
| Denmark | 2024-01-23 | 2025-11-18 | 2024-02-26 | 2024-05-28 | |
| Finland | 2024-01-18 | 2026-02-26 | 2024-01-30 | 2024-05-28 | |
| Germany | 2024-01-22 | 2026-03-06 | 2024-03-05 | 2024-05-28 | |
| Greece | 2024-02-21 | 2026-03-06 | 2024-03-06 | 2024-05-28 | |
| Hungary | 2024-01-30 | 2026-01-13 | 2024-02-23 | 2024-05-28 | |
| Netherlands | 2024-01-23 | 2025-11-26 | 2024-04-09 | 2024-05-28 | |
| Poland | 2024-01-24 | 2026-02-12 | 2024-01-31 | 2024-05-28 | |
| Spain | 2024-01-23 | 2026-03-19 | 2024-01-31 | 2024-05-28 | |
| Sweden | 2024-01-22 | 2026-01-20 | 2024-01-31 | 2024-05-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-112820
- Sponsor became aware
- 2025-12-19
- Date of breach
- 2024-07-31
- Submission date
- 2025-12-24
- Member states concerned
- Belgium, Czechia, Denmark, Finland, Germany, Greece, Hungary, Spain, Sweden, Netherlands, Poland
- Categories
- Regulation
- Areas impacted
- Other
- Benefit-risk balance changed
- No
- Description
- Informed consents were updated during the conduct of the trial, and re-consenting trial particpants was delayed by
more than 60 days at 1 trial center in 1 Country, impacting 5 participants. However, the delayed reconsent is not
considered to have an impact on participant safety and
data integrity. This is considered as persistent and
systematic site issue.
Refer to the attached document for more details. - Sponsor actions
- Investigation is ongoing at this time, and a CAPA will be implemented in accordance with the findings.
Refer to the attached document for more details.
| Organisation | City | Country | Type |
|---|---|---|---|
| PharmaSite AB | Malmo | Sweden | Other |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 234 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502531-18-00-GR-public | 5 |
| Protocol (for publication) | D1_Protocol 2022-502531-18-00-public | 5 |
| Protocol (for publication) | D4_ Patient facing documents-diary-body-weight-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-diary-weight-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-sample-diary-weight | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-eating-behaviour-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-iwqol-lite-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09 | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-phq-09-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36 | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-BE-eng | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-DE-ger | 2 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-PL-pol | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-sf-36-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-baseline-screening-SE-swe | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-BE-dut | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-BE-fre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-CZ-cze | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-DE-ger | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-ES-spa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-GR-gre | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-HU-hun | 1 |
| Protocol (for publication) | D4_ Patient facing documents-worksheet-sample-ssrs-since-lastvisit-SE-swe | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE-public | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-CZ | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DK | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-ES-spa-public | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FI | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-GR | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-HU | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-NL | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-PL-pol | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-SE-swe | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-document-study-details-page-CZ | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-document-study-details-page-HU-hun | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-document-study-details-page-PL-pol | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-notes-study-listing-registry-CZ | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-notes-study-listing-registry-CZ-cze | 5 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-notes-study-listing-registry-HU | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-ec-notes-study-listing-registry-PL | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-short-01-FI | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-short-02-FI | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-social-media-FI | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-advertisement-webpage-announcement-FI | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-BE-dut | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-BE-fre | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-CZ-cze | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-DE-ger | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-eng-BE | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-ES-spa | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-FI-fin | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-FI-swe | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-GR | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-HU-hun | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-NL | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-brochure-PL-pol | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-BE-dut | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-BE-eng | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-BE-fre | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-CZ-cze | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-DE-ger | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-ES-spa | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-FI-fin | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-FI-swe | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-GR | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-HU-hun | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-NL | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-flyer-PL-pol | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-BE-dut | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-BE-eng | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-BE-fre | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-CZ-cze | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-DE-ger | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-DK-dan | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-ES-spa | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-FI-fin | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-FI-swe | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-GR | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-HU-hun | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-NL | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-patient-poster-PL-pol | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-research-register-subject-FI-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-dut-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-eng-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-fre-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-BE-Sponsor-statment-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-DE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-DK | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-ES | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-GR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-HU | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-PL-public | 2-4 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-DE-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-DK | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-ES | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-FI | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-GR | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-HU | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-NL-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-PL | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-designated-person-SE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-gdpr-CZ | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-appendix-FI-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-CZ-public | 6-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-DE-public | 6-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-DK-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-ES-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-FI-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-GR-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-highlighted-CZ | 6-2 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-HU-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-NL-public | 6-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-PL-public | 6-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-re-consent-DE-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-re-consent-GR-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-re-consent-HU-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-SE-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-newborn-DE-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-DE-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-BE-dut-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-BE-eng-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-BE-fre-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-ES | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-FI-public | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-NL-public | 6-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-PL-public | 6-3 |
| Subject information and informed consent form (for publication) | L1_ ICF-re-consent-SE-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-designated-person-highlighted-cz | 1 |
| Subject information and informed consent form (for publication) | l1_icf-main-v-6-dk-not-public | 6 |
| Subject information and informed consent form (for publication) | l1_icf-main-v-6-dk-track-changes | 6 |
| Subject information and informed consent form (for publication) | l1_icf-optional-travel-services-gr | 1 |
| Subject information and informed consent form (for publication) | L1_Subject information-biobanking-HU | 3 |
| Subject information and informed consent form (for publication) | L2_ EU-ctr-list-of-documents | 4 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-research-rights-medicinal-products-DK | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-3d-secure-terms-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-3d-secure-terms-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-carrier-CZ | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-carrier-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-generic-image-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-generic-image-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-privacy-policy-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-card-privacy-policy-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-cardholder-faq-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-cardholder-faq-PL | 11 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-cardholder-screenshots-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-cardholder-web-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-dispute-form-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-fee-schedule-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-fee-schedule-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-greenphire-i2c-PL | 10 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-mockupdesign-icf-coloured-DE-deu | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-mockupdesign-icf-grey-DE-deu | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-mockupdesign-trialidcard-DE-deu | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-processdescription-prr-DE-deu | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-subject-info-clinical-trial-flyer-BE-dut | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-subject-info-clinical-trial-flyer-BE-eng | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-subject-info-clinical-trial-flyer-BE-fre | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-DE-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-DK-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-ES-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-FI-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-GR-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-NL-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-PL-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material-trialidcard-SE-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Trial-id-card-local-accompanying-letter-HU-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Trial-id-card-local-HU-public | 2 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-data-protection-es | 1 |
| Subject information and informed consent form (for publication) | l2_other-subject-information-material-webinars-es | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol lay synopsis_BE-dut-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol lay synopsis_CZ-cze-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol lay synopsis_DK-dan-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol lay synopsis_NL-dut-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary-local_CZ-cze-2022-502531-18-00-public | 5 |
| Synopsis of the protocol (for publication) | d1_protocol lay synopsis_BE-fre-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | d1_protocol lay synopsis_BE-ger-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_DE-ger-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_english-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_ES-spa-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_FI-fin-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_GR-gre-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_protocol lay synopsis_HU-hun-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | d1_protocol lay synopsis_PL-pol-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | d1_protocol lay synopsis-SE-swe-2022-502531-18-00-public | 1 |
| Synopsis of the protocol (for publication) | d1_protocol summary-local_HU-hun-2022-502531-18-00-public | 5 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | Germany | Acceptable 2024-01-15
|
2024-01-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-19 | Germany | Acceptable 2024-05-14
|
2024-05-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-03 | Germany | Acceptable 2024-08-30
|
2024-08-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Germany | Acceptable 2025-03-26
|
2025-03-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-28 | Germany | Acceptable 2025-06-12
|
2025-06-13 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-08 | Germany | Acceptable 2025-11-27
|
2025-11-27 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-18 | Acceptable | 2026-02-12 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-18 | Germany | Acceptable | 2026-02-04 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-18 | Acceptable | 2026-01-28 |